BAS EN 12442-1:2002
Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk
General Information
Status: Withdrawn
No. of pages: 19
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 08.10.2002
Technical committee:
Directive:
93/42/EEC, Medical devices
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Abstract
This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis).
Lifecycle
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Original document and degree of correspondence
- EN 12442-1:2000, identical